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FDA 510(k)

PRESTON LOWER LIMB CPM UNIT

K-Number: K852065 · 1985-07-19

ApplicantTherapeutic Equipment Corp.
Decision Date1985-07-19
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRESTON LOWER LIMB CPM UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Therapeutic Equipment Corp.. It received FDA 510(k) clearance on 1985-07-19 under 510(k) number K852065. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESTON LOWER LIMB CPM UNIT?

PRESTON LOWER LIMB CPM UNIT is a medical device that received FDA 510(k) clearance on 1985-07-19. The listed applicant is Therapeutic Equipment Corp.. The 510(k) number is K852065.

When did PRESTON LOWER LIMB CPM UNIT receive FDA 510(k) clearance?

PRESTON LOWER LIMB CPM UNIT received FDA 510(k) clearance on 1985-07-19, under 510(k) number K852065.

Who is the listed applicant for PRESTON LOWER LIMB CPM UNIT?

The FDA 510(k) record lists Therapeutic Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESTON LOWER LIMB CPM UNIT?

The FDA product code for PRESTON LOWER LIMB CPM UNIT is BXB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Therapeutic Equipment Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K862846TEC VARI-TRAC II TRACTION UNITK843637HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STIK843638HEALTH PULSE FA-222 POWER MUSCLE STIMUL

Related Devices (Code: BXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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